A Randomized Controlled Trial of Schema Therapy for Patients With Chronic Treatment Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 129
- 试验地点
- 12
- 主要终点
- Change from baseline in depression symptoms on the clinician-rated Hamilton-6 Rating Scale for Depression at 12 months after baseline measurements
研究概览
简要总结
The goal of this clinical study is to test a particular form of psychotherapy, called schema therapy, for people with difficult-to-treat depression (when depression is very lengthy or difficult to cure with antidepressive medication). Researchers will compare the group of participants receiving schema therapy to a group receiving standard psychotherapeutic treatment to see if schema therapy is more effective on depression symptoms and other important issues for the participant.
The main question the study aims to answer is:
- Can schema therapy be a more effective treatment for difficult-to-treat depression than other forms of psychotherapy offered in psychiatry today?
People who have difficult-to-treat depression are a special group of patients who are more strained in a wide range of areas of life than other people with depression. They also more often have childhood trauma, as well as simultaneous personality disorder or personality traits that brings challenges in everyday life. Currently we can not offer a sufficiently effective psychiatric treatment for this group of people.
Schema therapy was developed to help patients who do not have sufficient effect of the usual psychotherapeutic treatments. It also addresses personality disorders or problematic traits and childhood trauma directly in the therapy.
The project will include 129 participants in total, of which half will receive schema therapy.
Treatment is provided at six psychiatric centers in both the Southern and the Capital Regions of Denmark.
Participants receiving schema therapy will be given 30 sessions of weekly therapy, as well as the opportunity for the rest of the standard care package in the Danish secondary mental health system, that is, treatment with psychopharmacological medicine and meetings with next-to-kin and other parts of the participant's support system.
Participants receiving the standard treatment will receive about 6-20 sessions of individual or group therapy with a range of other psychotherapies that are not schema therapy, as well as the other parts of the standard care package as listed above.
If schema therapy proves to be more effective for treatment of difficult-to-treat depression than the treatment offered today, it may give rise to more extended use of schema therapy in and outside psychiatry. This means that the toolbox for the treatment of difficult-to-treat depression is expanded with a new specialized and effective psychotherapeutic tool.
详细描述
Aims of study:
The central aim of this study is to investigate whether Schema Therapy (ST) of longer duration (up to 30 sessions) outperforms the current treatment as usual (TAU) for patients with chronic and treatment resistant depression (CTRD) on depression outcomes at 12 months after baseline measurements, as well as at 6 and 24 months time points after baseline. It is hypothesized that the treatment effect in ST is mediated by changes in the psychological phenomenons called modes, namely Healthy Adult Mode and Vulnerable Child Mode, and that treatment effect is moderated by childhood adversity.
A second aim is to expand the understanding of what constitutes a successful therapy by investigating relevant secondary outcomes at the same time points. When dealing with chronic and/or treatment resistant illnesses, other success criteria such as level of functioning, personal recovery, or a completely different, patient-generated outcome, might be more obtainable than improvements in illness symptoms alone.
Also, it will be investigated whether schema therapy is more advantageous from a health economic aspect, both in terms of quality of life for the patient and from an economical societal perspective.
The final aim for the study is to investigate and define the population of patients with CTRD. It will be attempted to refine the Maudsley Staging Model for CTRD by including (failed) psychotherapy trials. As a part of this, it will be investigated whether patients with Treatment Resistant Depression (TRD) and Chronic Depression (CD), respectively, can be adequately understood as exhibiting similar characteristics in symptoms and response to treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to treatment condition and to the hypotheses of the study. Different assessors will be assigned at each measurement time point.
Participants and therapists are instructed to withhold information about the treatment from the research team. The research team has no clinical contact with the participants from assessment to end of intervention, and the assessors have no knowledge about the participant's randomization status at the end of intervention.
Statistical analyses will be made with the two intervention groups coded as 'A' and 'B'. The results will remain coded when writing the outcome section of the relevant scientific articles, and the code will only be broken at the conclusion of this write-up.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants have at the time of inclusion been referred to treatment for depression as a primary diagnosis in a psychiatric clinic
- •Participants should meet the diagnosis of chronic or treatment-resistant depression as follows:
- •Clinical major depression as measured by the M.I.N.I. diagnostic interview: duration minimum two years OR persistent after = 2 trials of antidepressants from different classes, in an adequate dosage and time period (= 4 weeks) OR moderate treatment resistance as measured on the MSM-scale, score > 6
- •Minimum a score of 9 points on the Hamilton Rating Scale for Depression 6 (HAMD-6), corresponding to moderate to severe depression
排除标准
- •Alcohol or substance abuse
- •Bipolar or psychotic disorder
- •Acute suicidal risk
- •Mental disability (estimated IQ < 70)
- •Non-Danish speaker
- •Known to be pregnant at time of inclusion
- •Psychiatric comorbidity is not an exclusion criteria, until the comorbid disorder is understood to be the primary psychiatric problem and as such the patient would be treated in a different care package, e.g., for Post-Traumatic Stress Disorder
结局指标
主要结局
Change from baseline in depression symptoms on the clinician-rated Hamilton-6 Rating Scale for Depression at 12 months after baseline measurements
时间窗: From baseline measurements to end of treatment (of schema therapy) at 12 months
6-item clinician rated instrument
次要结局
- Change from baseline in subjective functional impairment as measured on the Work and Social Adjustment Scale (WSAS) at 24 months after baseline measurements(From baseline measurements to after 24 months)
- Change from baseline in personal recovery after mental illness as measured on the INSPIRE-O Brief at 24 months after baseline measurements(From baseline measurements to after 24 months)
- Level of negative effects of treatment as measured on the Negative Effects Questionnaire (NEQ) at 12 months after baseline assessments(At end of treatment (Schema therapy) at 12 months after baseline assessments)
- Prediction for treatment effect of negative expectancies for change in depression symptoms as measured on the Depression Change Expectancy Scale-pessimistic (DCES-P) items at baseline assessments(At baseline only)
- Early maladaptive schemas as measured after 6 months on the Young Schema Questionnaire 3 Short Form (YSQ-S3)(From baseline measurements to end of treatment at 6 months (both arms))
- Early maladaptive schemas as measured after 24 months on the Young Schema Questionnaire 3 Short Form (YSQ-S3)(From baseline measurements to end of treatment at 24 months (both arms))
- Remission from depression at 12 months after baseline as measured on the Hamilton-6 Rating Scale for Depression(From baseline measurements to end of treatment (Schema therapy) at 12 months)
- Remission from depression at 24 months after baseline as measured on the Hamilton-6 Rating Scale for Depression(From baseline measurements to follow up at 24 months)
- Change from baseline in subjective functional impairment as measured on the Work and Social Adjustment Scale (WSAS) at 12 months after baseline measurements(From baseline measurements to end of treatment (of schema therapy) at 12 months)
- Change from baseline in psychological well-being as measured on the WHO-5 Well-Being Index at 6 months after baseline measurements(From baseline measurements to end of treatment (Treatment at usual) at 6 months)
- Change from baseline in psychological well-being as measured on the WHO-5 Well-Being Index at 24 months after baseline measurements(From baseline measurements to after 24 months)
- Change from baseline in depression symptoms on the Hamilton-6 Rating Scale for Depression at 6 months after baseline measurements(From baseline measurements to end of treatment (Treatment at usual) at 6 months)
- Change from baseline in depression symptoms on the Hamilton-6 Rating Scale for Depression at 24 months after baseline measurements(From baseline measurements to after 24 months)
- Change from baseline in subjective functional impairment as measured on the Work and Social Adjustment Scale (WSAS) at 6 months after baseline measurements(From baseline measurements to end of treatment (Treatment at usual) at 6 months)
- Change from baseline in personal recovery after mental illness as measured on the INSPIRE-O Brief at 6 months after baseline measurements(From baseline measurements to end of treatment (Treatment at usual) at 6 months)
- Change from baseline in reactions to anger as measured on the Dimensions of Anger Reactions - Revised (DAR) at 6 months after baseline assessments(From baseline measurements to end of treatment (Treatment at usual) at 6 months)
- Change from baseline in reactions to anger as measured on the Dimensions of Anger Reactions - Revised (DAR) at 12 months after baseline assessments(From baseline measurements to end of treatment (Schema therapy) at 12 months)
- Level of negative effects of treatment as measured on the Negative Effects Questionnaire (NEQ) at 6 months after baseline assessments(At end of treatment (Treatment at usual) at 6 months after baseline assessments)
- Change from baseline in psychological well-being as measured on the WHO-5 Well-Being Index at 12 months after baseline measurements(From baseline measurements to end of treatment (Schema therapy) at 12 months)
- Change from baseline in personal recovery after mental illness as measured on the INSPIRE-O Brief at 12 months after baseline measurements(From baseline measurements to end of treatment (Schema therapy) at 12 months)
- Change from baseline in reactions to anger as measured on the Dimensions of Anger Reactions - Revised (DAR) at 24 months after baseline assessments(From baseline measurements to after 24 months)
- Level of negative effects of treatment as measured on the Negative Effects Questionnaire (NEQ) at 24 months after baseline assessments(At follow-up 24 months after baseline assessments)
- Changes in 1-2 patient defined problems as measured on the Psychological Outcome Profiles (PSYCHLOPS) at end of treatment for Treatment at usual 6 months after baseline assessments(From baseline measurements to end of treatment (for Treatment at usual-arm only) at 6 months)
- Changes in anger processing as measured on the Metacognitive Anger Processing scale Short Version (MAP) at 6 months after baseline assessments(From baseline measurements to end of treatment (Treatment As Usual) at 6 months)
- Changes in anger processing as measured on the Metacognitive Anger Processing scale Short Version (MAP) at 24 months after baseline assessments(At follow-up 24 months after baseline assessments)
- Changes in repetitive negative thinking as measured on the Perseverative Thinking Questionnaire (PTQ) at 12 months after baseline assessments(From baseline measurements to end of treatment (Schema therapy) at 12 months)
- Changes in anxiety symptoms as measured on the Symptom Checklist-10 (SCL-10) at 6 months after baseline assessments(From baseline measurements to end of treatment (Treatment As Usual) at 6 months)
- Changes in anxiety symptoms as measured on the Symptom Checklist-10 (SCL-10) at 24 months after baseline assessments(At follow-up 24 months after baseline assessments)
- Changes in anxiety symptoms as measured on the Symptom Checklist-10 (SCL-10) at 12 months after baseline assessments(From baseline measurements to end of treatment (Schema therapy) at 12 months)
- Changes in 1-2 patient defined problems as measured on the Psychological Outcome Profiles (PSYCHLOPS) at end of treatment for Schema therapy, 12 months after baseline assessments(From baseline measurements to end of treatment (for Schema Therapy-arm only) at 12 months)
- Changes in anger processing as measured on the Metacognitive Anger Processing scale Short Version (MAP) at 12 months after baseline assessments(From baseline measurements to end of treatment (Schema therapy) at 12 months)
- Changes in repetitive negative thinking as measured on the Perseverative Thinking Questionnaire (PTQ) at 6 months after baseline assessments(From baseline measurements to end of treatment (Treatment As Usual) at 6 months)
- Changes in repetitive negative thinking as measured on the Perseverative Thinking Questionnaire (PTQ) at 24 months after baseline assessments(At follow-up 24 months after baseline assessments)
- Schema modes as mediators of treatment effect after 6 months, as measured on the Schema Mode Inventory (SMI)(From baseline measurements to end of treatment at 6 months (both arms))
- Response to treatment at 6 months after baseline as measured on the Hamilton-6 Rating Scale for Depression(From baseline measurements to end of treatment (Treatment As Usual) at 6 months)
- Changes in health-related quality of life as measured on the Euro-Qol-5D (EQ-5D) at 12 months after baseline assessments(From baseline measurements to end of treatment (Schema therapy) at 12 months)
- Changes in health-related quality of life as measured on the Euro-Qol-5D (EQ-5D) at 24 months after baseline assessments(At follow-up 24 months after baseline assessments)
- Schema modes as mediators of treatment effect after 12 months, as measured on the Schema Mode Inventory (SMI)(From baseline measurements to end of treatment at 12 months (Treatment as Usual-arm only))
- Early maladaptive schemas as measured after 12 months on the Young Schema Questionnaire 3 Short Form (YSQ-S3)(From baseline measurements to end of treatment at 12 months (Treatment As Usual arm only))
- Response to treatment at 24 months after baseline as measured on the Hamilton-6 Rating Scale for Depression(From baseline measurements to follow up at 24 months)
- Changes in health-related quality of life as measured on the Euro-Qol-5D (EQ-5D) at 6 months after baseline assessments(From baseline measurements to end of treatment (Treatment As Usual) at 6 months)
- Schema modes as mediators of treatment effect after 24 months, as measured on the Schema Mode Inventory (SMI)(From baseline measurements to end of treatment at 24 months (both arms))
- Response to treatment at 12 months after baseline as measured on the Hamilton-6 Rating Scale for Depression(From baseline measurements to end of treatment (Schema therapy) at 12 months)
- Remission from depression at 6 months after baseline as measured on the Hamilton-6 Rating Scale for Depression(From baseline measurements to end of treatment (Treatment As Usual) at 6 months)
研究者
Stine Bjerrum Møller
Head of Research Unit, Associate Professor
Region of Southern Denmark